ArtiCure Isolator Transpolar pen Manual de instruções de utilização - Página 4

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INDICATION FOR USE

•
™
The Isolator
sterile, single use electrosurgery
device intended to ablate cardiac
tissue during cardiac surgery using
radiofrequency (RF) energy when
connected directly to the ASU or to the
ASU Source Switch in Ablation mode.
•
When the Pen is connected to the
ASU Source Switch in Auxiliary mode,
it may be used for temporary cardiac
sensing, recording, stimulation, and
temporary pacing during the
evaluation of cardiac arryhthmias.
CONTRAINDICATIONS
•
The device is not intended for
contraceptive tubal coagulation
(permanent female sterilization).
•
Do not ablate directly on cardiac
valves.

POTENTIAL COMPLICATIONS

Possible complications related to the
creation of spot or linear lesions in cardiac
and soft tissues are:
•
Tissue perforation
•
Postoperative embolic complications
•
Extension of extracorporeal bypass
•
Perioperative heart rhythm disturbance
(atrial and/or ventricular)
•
Pericardial effusion or tamponade
•
Injury to the great vessels
•
Valve leaflet damage
•
Conduction disturbances
(SA/AV node)
•
Acute ischemic myocardial event
4
™
Transpolar
Pen is a